
Oncol Res Treat 2020;43(suppl 1):1–265Abstracts 55
Inhalt
2018
Index
2018
608
Beacon Crc: a Randomized, Phase 3 Study of Encorafenib
(ENCO) and Cetuximab (CETUX) with or without Binimetinib
(BiNI) vs. Choice of Either Irinotecan or Folri Plus Cetux in
BRAF V600E–Mutant Metastatic Colorectal Cancer (mCRC)
Arndt Vogel 1; Susanna Hegewisch-Becker 2; Gerald Prager 3;
Gunnar Folprecht 4; Michael Stahl 5; Scott Kopetz 6; Axel Grothey 7;
Eric van Cutsem 8; Rona Yaeger 9; Harpreet Wasan 10; Takayuki Yoshino 11;
Jayesh Desai 12; Fortunato Ciardello 13; Ashwin Gollerkeri 14; Kati Maharry 14;
Fotios Loupakis 15; Hong Y 16; Neeltje Steeghs 17; Tormod Kyrre Guren 18;
Hendrik-Tobias Arkenau 19; Pilar García-Alfons 20; Victor Sandor 14;
Janna Christy-Bittel 21; Lisa Anderson 14; Josep Tabernero 22
1Gastroenterology, Hepatology and Endocrinology, Hannover Medical School,
Hannover, Deutschland
2HOPE-Practice for Oncology, Hamburg, Deutschland
3Department of Medicine, Medical University of Vienna, Vienna, Österreich
4University Clinic Dresden, Oncology Department, Dresden, Deutschland
5Department of Medical Oncology and Hematology, Evang. Kliniken Essen-
Mitte, Essen, Deutschland
6UT MD Anderson Cancer Center, Houston, TX, United States
7Mayo Clinic, Rochester, Minnesota, United States
8UZ Leuven-Campus Gasthuisberg, Leuven, Belgien
9Memorial Sloan-Kettering Cancer Center, New York, NY, United States
10Hammersmith Hospital, Department of Cancer Medicine, London, United
Kingdom
11Department of Gastroenterology and Gastrointestinal Oncology, National
Cancer Hospital East, Kashiwa, Japan
12Royal Melbourne Hospital and Peter MacCallum Cancer Centre, Walter and
Aliza Hall Institute, Parkville, VIC, Australien
13Università degli Studi della Campania L., Dipartimento di Medicina di
Precisione, Napoli, Italien
14Array BioPharma Inc, Boulder, CO, United States
15Medical Oncology Unit 1, Clinical and Experimental Oncology Department,
Veneto Institute of Oncology IOV-IRCCS, Padua, Italien
16Asan Medical Center, Seoul KR, Seoul, Südkorea
17Netherlands Cancer Institute, Amsterdam, Niederlande
18Oslo University Hospital, Oslo, Norwegen
19Sarah Cannon Research Institute, HCA Healthcare, London, United Kingdom
20Medical Oncology Department. Hospital General Universitario Gregorio
Marañón, Madrid, Spanien
21Array BioPharma Inc, Cambridge, MA, United States
22Vall d’Hebron University Hospital, Barcelona, Spanien
Purpose: BRAF V600E mutations are identied in up to 15% of mCRC
patients (pts) and confer a poor prognosis. Objective response rates
(ORR) to chemotherapy in ≥ 2 line are generally less than 10%, with me-
dian progression-free survival (PFS) and overall survival (OS) of approx-
imately 2 and 4-6 months, respectively. A 30-patient safety lead-in with
ENCO+BINI+CETUX showed acceptable safety and encouraging activity
in these pts.
Methods: e BEACON CRC Study (NCT02928224) was a multicenter,
randomized, open-label, phase 3 study to evaluate ENCO+CETUX with/
without BINI (triplet or doublet) vs. choice of irinotecan or FOLFIRI +
CETUX (control) in pts with BRAF V600E‒mutant mCRC who had pro-
gressed aer 1 or 2 prior palliative regimens. e primary endpoints were
OS and ORR (by blinded central review) comparing triplet to control arm;
secondary end points included OS for the doublet arm as well as PFS and
safety.
Results: 665 pts were randomly assigned to the triplet (n = 224), doublet
(n = 220), or control arm (n = 221). Median OS was 9.0 months (95% CI,
8.0-11.4) for the triplet and 5.4 months (95% CI, 4.8-6.6) for the control
regimen (HR, 0.52; 95% CI, 0.39-0.70, p < .0001). Conrmed ORR of the
triplet was 26% and 2% for the control (p < .0001). Median OS for the
doublet combination was 8.4 months (95% CI, 7.5-11.0) (HR vs. control,
0.60; 95% CI, 0.45-0.79; P = .0003). Adverse events were as anticipated
based on prior trials with each combination. Grade 3 or 4 adverse events
were seen in 58%, 50% and 61% of pts in the triplet, doublet and control
arm, respectively.
Conclusions: ENCO+BINI+CETUX improved OS and ORR in pts with
BRAF V600E-mutant mCRC when compared with current standard of
care chemotherapy and had a safety prole consistent with the known
safety prole of each agent. is targeted therapy regimen should be a
new standard of care for this patient population.
e study was published at ESMO World GI congress 2019.
Conicts of Interest: AV: honoraria from Pierre Fabre.; GP: speaker, advisory
board member, other type of consultant: Celgene, Bayer, Roche, Shire, Halozyme,
Lilly, BMS, Pierre Fabre, Amgen, Servier, MSD, Merck, Taiho; GF: honoraria from
Merck, Roche, Sano-Aventis, Lilly, Bayer, Servier, Mundipharma, BMS, MSD;
Research funding: Merck; SK: Stock and Other Ownership Interests: Molecular-
Match, Navire Consulting or Advisory Role: Roche, Genentech, EMD Serono,
Merck, Karyopharm erapeutics, Amal erapeutics, Navire Pharma, Sympho-
gen, Holy Stone, Biocartis, Amal erapeutics, Amgen, Novartis, Eli Lilly, Boeh-
ringer Ingelheim; AG: Honoraria: Elsevier, Aptitude Health Consulting or Adviso-
ry Role: Genentech (Inst), Bayer (Inst), Bristol-Myers Squibb (Inst), Eli Lilly (Inst),
Boston Biomedical (Inst), Amgen (Inst), Array BioPharma (Inst), Guardant Health
(Inst), Daiichi Sankyo (Inst), Research Funding: Genentech (Inst), Bayer (Inst),
Pzer (Inst), Eisai (Inst), Eli Lilly (Inst), Boston Biomedical (Inst), Daiichi Sankyo
(Inst), Array BioPharma (Inst); Travel, Accommodations, Expenses: Genentech,
Bayer, Bristol-Myers Squibb, Boston Biomedical, Amgen, Boehringer Ingelheim,
Merck Sharp & Dohme; EVC: Consulting or Advisory Role: Bayer, Eli Lilly, Roche,
Servier, Bristol-Myers Squibb, Celgene, Merck Sharp & Dohme, Merck KGaA,
Novartis, AstraZeneca; Research Funding: Amgen (Inst), Bayer (Inst), Boehringer
Ingelheim (Inst), Eli Lilly (Inst), Novartis (Inst), Roche (Inst), Celgene (Inst),
Ipsen (Inst), Merck (Inst), Merck KGaA (Inst), Servier (Inst), Bristol-Myers Squibb
(Inst); RY: Research Funding: Array BioPharma, GlaxoSmithKline, Novartis;
Travel, Accommodations, Expenses: Array BioPharma; Speakers’ Bureau: Sysmex;
Research Funding: Symphogen; Patents, Royalties, Other Intellectual Property:
Patent licensed by Biocartis (Inst); HW: Honoraria: Merck KGaA, Celgene, Sirtex
Medical, Servier, Array BioPharma, Shire, Genentech, ERYTECH Pharma; Con-
sulting or Advisory Role: Roche Pharma AG, SITEX Medical, ERYTECH Pharma,
Shire, Incyte; Speakers’ Bureau: Sirtex Medical, Celgene, Merck KGaA, Servier;
Research Funding: Sirtex Medical (Inst), Merck KGaA (Inst), Pzer (Inst), Merck
Sharp & Dohme (Inst); TY: Research Funding: Chugai Pharma (Inst), Sano (Inst),
Sumitomo Dainippon (Inst), GlaxoSmithKline (Inst); JD: Consulting or Advisory
Role: Bionomics, Eli Lilly, Eisai, BeiGene, Ignyta (Inst); Research Funding: Roche
(Inst), GlaxoSmithKline (Inst), Novartis (Inst), Bionomics (Inst), MedImmune
(Inst), BeiGene (Inst), Eli Lilly (Inst), Bristol-Myers Squibb (Inst); FC: Consult-
ing or Advisory Role: Genentech, Merck KGaA, Bayer, Amgen, Pzer; Research
Funding: Merck KGaA (Inst), Genentech (Inst), Servier (Inst), Symphogen (Inst),
Amgen (Inst), Bayer (Inst), Merck Sharp & Dohme (Inst), Bristol-Myers Squibb
(Inst), Ipsen (Inst); AG: Employment: Array BioPharma, Alnylam (I), Bluebird Bio
(I); Stock and Other Ownership Interests: Array BioPharma, Alnylam (I); Hon-
oraria: Bluebird Bio (I); Patents, Royalties, Other Intellectual Property: Receives
royalties from Yale University on an antibody used in nephrology basic research
(I); KM: Employment: Array BioPharma; Stock and Other Ownership Interests:
Array BioPharma; Travel, Accommodations, Expenses: Array BioPharma; NS:
Research funding (inst): ompany: AstraZeneca/MedImmune, Bayer, Bristol-Myers
Squibb, Novartis, GlaxoSmithKline, Pzer, Roche, Genentech/Roche, Boehringer
Ingelheim, Blueprint Medicines, AB Science, Deciphera, Blueprint Medicines,
Genentech, Merck Sharp & Dohme, Amgen, Merus, Lilly, Incyte; VS: Employment:
Array BioPharma; Leadership: Array BioPharma; Stock and Other Ownership
Interests: Array BioPharma; JCB: Employment: Array Biopharma; Stock and Other
Ownership Interests: Array Biopharma, Gilead Sciences; LA: Array employee;
Employment: Array BioPharma; Stock and Other Ownership Interests: Array
BioPharma; Travel, Accommodations, Expenses: Array BioPharma; JT: Consulting
or Advisory Role: Bayer, Boehringer Ingelheim, Eli Lilly, MSD, Merck Serono,
Novartis, Sano, Taiho Pharmaceutical, Merrimack, Peptomyc, Rafael Pharmaceu-
ticals, Symphogen, Chugai Pharma, Ipsen, Merus, Pzer, Seattle Genetics, Array
BioPharma, AstraZeneca, BeiGene, Genentech, Genmab, Halozyme, Imugene
Limited, Inection Biosciences Limited, Kura, Menarini, Molecular Partners,
Pharmacyclics, ProteoDesign SL, Roche, Seattle Genetics, Servier, VCN Bioscienc-
es, Biocartis, Foundation Medicine, HalioDX SAS, Roche Diagnostics; FT, YH, TG,
TA, PGA have nothing to dislose.
DKK_Abstracts_001-246.indd 55 11/02/20 12:05 PM
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